Phase 1b Study of CS-7017 in Combination With Erlotinib in Subjects With Metastatic or Unresectable Locally Advanced Non-small Cell Lung Cancer (NSCLC) Who Failed First-line Therapy
Inclusion Criteria:
- Histologically or cytologically confirmed unresectable locally advanced or metastatic
(stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)
- Recurrent disease (either no response to treatment or subsequent relapse after an
objective response) that has progressed after first-line platinum based therapy
- Male or female ≥ 18 years of age
- Anticipation of more than 3 months survival
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
- Adequate organ and bone marrow function
Exclusion Criteria:
- Prior Tyrosine Kinase Inhibitor (TKI) therapy
- Anticipation of need for a major surgical procedure or radiation therapy during the
study
- Remaining influence of previous therapies such as radiotherapy, surgery,
immunotherapy within 4 weeks prior to start of study treatment
- Treatment with anticancer medication within 4 weeks before study treatment, currently
enrolled in another investigational drug study, or enrolled in another
investigational drug study within 4 weeks of start of treatment
- History of any of the following events within 6 months prior to start of study
treatment: myocardial infarction, severe/unstable angina pectoris,
coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I
Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction,
pulmonary embolism, deep vein thrombosis, or other clinically significant
thromboembolic event; clinically significant pulmonary disease (eg, severe
Chronic-Obstructive Pulmonary Disease (COPD) or asthma)
- Severe edema, ascites fluid, pericardial or pleural effusion or pericardial
involvement with the tumor within 6 months prior to start of study treatment, or
which require steroid therapy/ diuretic therapy
- Subjects with brain metastasis (defined as untreated, symptomatic or requiring
steroids or anticonvulsant medications to control associated symptoms)
- Subjects with clinically significant active infection which requires antibiotic
therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or
human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy
- Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks),
inflammatory bowel disease, or partial bowel obstruction
- Diabetes mellitus requiring insulin, or a history of poor serum glucose control with
the use of non-insulin diabetes medications
- Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study
treatment
- History of a second malignancy, with the exception of in situ cervical cancer or
adequately treated basal cell or squamous cell carcinoma of the skin
- Poorly-controlled blood pressure as judged by the Investigator